According to the announcement from Shanghai RAAS (002252.SZ), the company recently disclosed the registration information for a Phase IIb clinical trial on the National Medical Products Administration's drug clinical trial registration and information disclosure platform. The trial is titled: An open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, efficacy, and PK/PD characteristics of SR604 injection in patients with Hemophilia A/B and congenital factor VII deficiency.

As indicated in the announcement, SR604 injection is intended for the preventive treatment of bleeding in patients with Hemophilia A/B and congenital factor VII deficiency. SR604 is administered via subcutaneous injection to prevent and treat bleeding. The Part A dose-escalation Phase I trial (single-dose phase) has completed the enrollment and administration of subjects in 6 dose groups: 0.025mg/kg, 0.05mg/kg, 0.1mg/kg, 0.2mg/kg, 0.4mg/kg, and 0.8mg/kg; as well as the Part B efficacy exploration Phase IIa trial (multiple-dose phase) with 2 dose groups: 0.05mg/kg and 0.1mg/kg, with subjects receiving treatment once every two weeks for a total of 6 months. Existing safety and preliminary efficacy data support the initiation of the Part C efficacy exploration Phase IIb trial (multiple-dose phase), which will conduct a trial with a 0.4mg/kg dose group administered once every 4, 6, or 8 weeks for a total of 6 months